Method of manufacturing a multiple component device

ABSTRACT

Disclosed are methods of manufacturing a product from individual components comprising the steps of providing data regarding components to a customer; permitting the customer to request a product comprising the combination of the components; transmitting the request to a first location remote from the customer; receiving one of the components at a first location; transporting the components from a first location to a second location; assembling the components into the desired product at the second location; and transporting the assembled product to the customer.

PRIORITY INFORMATION

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 10/398,432, titled “METHOD OF MANUFACTURINGA MULTIPLE COMPONENT DEVICE,” for which the last of the 35 U.S.C. 371(c)(1), (c)(2), and (c)(4) requirements were received in the UnitedStates Patent and Trademark Office on Apr. 26, 2004, which is a NationalStage of International Application No. PCT/US2000/34124, filed Dec. 14,2000, which claims priority to U.S. Provisional Patent Application No.60/170,659, filed Dec. 14, 1999. The entirety of each of theabove-referenced applications is hereby incorporated by reference andmade part of this specification.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to methods of manufacturing devices,and specifically to methods of manufacturing devices comprised ofmultiple component products.

2. Description of the Related Art

Many manufacturers produce a comprehensive line of component productswhich are designed to interconnect and function together. It is oftendesirable for such manufacturers to sell their components separatelybecause the varying needs of their customers would not be readilysatisfied by any single combination of components, and it is frequentlynot economically feasible to assemble the components in accordance withthe individual needs of every customer at the manufacturing site. Inaddition, in some industries, manufacturers make individual componentswhich are capable of being used in combination with the components ofother manufacturers in the industry.

As a consequence, the customer usually is faced with the inconvenienttask of obtaining the desired component parts from one or moremanufacturers and then combining them in the desired configuration. Whena customer has a continuous need for such a combination of components,the burden of ordering the components and putting them together maybecome very time-consuming and expensive.

The problem is especially evident in the medical device industry. Forexample, medical practitioners often require a variety of components tocreate a desired intravenous (IV) set. The components of an IV set mayinclude IV drip bags, medical tubing, needleless injection sites,Y-sites, luer connectors, etc. Many of these components are repeatedlyused together in certain configurations for specific applications at agiven hospital or other care center, but the components are generallysold separately by separate manufacturers.

Some medical device manufacturers have permitted their customers toorder combinations of such components pre-assembled. However, asdescribed below, the expense and delay heretofore associated withpre-assembled combinations has often been prohibitive, especially inview of the increasing cost constraints placed upon medicalpractitioners and medical device companies by insurance companies andthe consuming public. Thus, despite the recurrent use of a certaincombination at a facility, many medical practitioners have still beenforced to order the components separately and then assemble them onsite.

An example of a combination of IV set component parts that might bedesired at a given hospital is shown in FIG. 1. In this example, a firstend of a section of medical tubing 20 is inserted into a first inlet 22of a Y-site 24. A female luer 26 and a CLAVE 28 fluid connector(manufactured by ICU Medical, Inc. of San Clemente, Calif.) are attachedin series to the opposite end of the medical tubing 20. A PIGGY LOCKconnector 30 (also available from ICU Medical, Inc.) is attached to asecond inlet 32 of the Y-site 24, and a section of medical tubing 36 iscoupled to the outlet port 38 of the Y-site 24. The PIGGY LOCK connectoris attached to tubing 37 which is attached to a spike 35. The tubing 36is connected to a luer lock 39 at its opposite end.

The typical prior art procedure for providing a pre-assembledcombination of such an IV set is outlined below. A customer firstcontacts a manufacturing representative of a company which offers one ormore of the components of the desired combination. The manufacturingrepresentative then informs the manufacturer of the request and anemployee of the manufacturer must then determine whether the requestedcombination can be provided in view of applicable governmentalregulations.

Assuming the combination is permitted by such regulations, themanufacturing representative then arranges for another employee to puttogether a sample of the desired combination from the component parts.The sample is then sent to a facility for medical sterilization andpackaging, returned from the sterilization facility, and then sent tothe customer.

In this process, if the manufacturer does not make all of the componentsof the desired combination, the manufacturer may need to obtain one ormore of the components from another manufacturer.

It typically takes about ten days from the time the customer originallyrequests the sample to the time the customer receives the sample. Thecustomer then evaluates the sample to determine whether it issatisfactory. If the customer approves of the sample, the customer mustgenerally place a minimum bulk order of the combination with themanufacturing representative. In most cases, the customer does not havethe option of ordering the desired combination in small quantities.

Bulk orders are usually required because the process of assembling andpackaging a specific combination requires reconfiguration of theassembly process and special attention by the manufacturing anddistribution personnel, entailing additional expenses which are onlycompensable by the profits resulting from an order of substantial size.

The assembly process usually takes an extended period of time. Afterassembly, the products must be sterilized and packaged. The process ofsending the products to the sterilization facility, performing thesterilization and packaging, and then sending them back to themanufacturer takes more time. As a consequence of the various delays andinefficiencies, the complete process takes approximately four to sixmonths from the time the customer first contacts the manufacturingrepresentative to the time the customer receives the first bulk order.

Another problem associated with this procedure relates to the end costof the product. As may be appreciated, the cost of labor is the primarycost associated with producing the product. In this process, asubstantial number of man hours are spent in this process preparing thesample product. More man hours, and capital expenditure, are required toproduce the minimum order of the product. Because of the substantialman-hours associated with the preparation of the product, the cost ofthe product is very high. This is especially true when viewed inrelation to the number of products produced. This cost is passed on tothe consumer, after application of a profit margin by the medical devicesupplier and hospital. In addition, they often produce several times theamount of the product ordered and keep the remaining product ininventory so that subsequent orders can be filled more quickly.

There is thus a need for an improved method of manufacturingpre-assembled combinations of component parts.

It is an object of the invention to provide a method in which thecustomer is given more information at the beginning of the orderingprocess and the assembly process and wherein the assembly andtransportation are efficiently controlled in a manner which provides theproduct more quickly and at a significant reduction in cost.

SUMMARY OF THE INVENTION

The present invention is a method of manufacturing a product from atleast two individual components. In general, this method comprises thesteps of providing data regarding at least a first and a secondcomponent to a customer; permitting said customer to request a productcomprising the combination of at least said first and said secondcomponent; transmitting said request to a first location remote fromsaid customer; receiving at least one of said first and secondcomponents at said first location; transporting said first and secondcomponents from said first location to a second location; assemblingsaid first and second components into the desired product at said secondlocation; and transporting said assembled product to said customer.

Preferably, data regarding each individual component and combinations ofmultiple components is available on a database. The customer accessesthis database to determine the availability of particular combinationsof components.

The database is associated with a program which permits the customer toplace an order for an approved combination of components.

In the preferred embodiment, the method is used to create amulti-component medical device, such as an IV set.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an example of a combination of medical devicecomponent products;

FIG. 2 is a flowchart illustrating the steps of the method of thepresent invention;

FIG. 3 is a schematic illustrating the interrelationship between thevarious locations and activities associated with the method of thepresent invention; and

FIG. 4 is a schematic illustrating the method of the present inventionas used to create the product illustrated in FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention overcomes the expense and delay previouslyassociated with providing customers with combinations of componentproducts by using a novel method of bringing all of the componentstogether for assembly, performing the assembly process in an efficientand economical manner, and delivering the assembled components directlyto the customer.

The method of the present invention is broadly illustrated in FIG. 2. Ina first step S1, a number of component parts are made generallyavailable to a customer by a vendor. These components may be provided bya number of suppliers or manufacturers. In step S2, a customer places anorder with the vendor for a product comprising at least two of theassembled components which are available.

In step S3, the vendor requests each of the assembled componentsrequired to produce the combination from the individual suppliers ormanufacturers. In step S4, these individual components are delivered toa single location where they are combined in bulk. These unassembled butamassed components are then delivered to an assembly location, where instep S5 they are assembled into the desired combination of thecomponents.

In an optional step S6, the assembled combinations are subjected topost-production processing, such as packaging or sterilization. Thisprocessing may take place in a remote location from the location ofassembly.

Finally, in step S7, the completed products are shipped directly to theconsumer which placed the order in step S2 or an address to which theconsumer wishes the products to be delivered.

In accordance with the present invention, the method illustrated inflowchart form in FIG. 2 preferably occurs at several locations andinvolving several parties, the interrelationship of which is illustratedin FIG. 3.

As illustrated in FIG. 3, according to the present invention a vendorpreferably provides a customer 40 with means for ascertaining allpossible combinations of available components. Preferably, this meansprovides the customer with information regarding each individualcomponent, as well as combinations thereof. In addition, the customer isprovided with information regarding which combinations are prohibited byapplicable government regulations.

This means may include a catalog, a telephone system, or preferably, acomputer program with a comprehensive database. This database includesinformation regarding each component, such as the specifications of thecomponent and the like. In the case of a computer database, anillustration of the component is provided on a viewing screen.

A program associated with the database permits the customer to obtaininformation regarding proposed combinations of individual components. Inthis arrangement, a customer may utilize a computer at a remote locationto access a main computer associated with the vendor which contains thedatabase. The customer's computer communicates with the main computervia the Internet, a telephone link or other means well known in the art.Of course, one or more access computers may be provided at the locationof the vendor which the customer may use to obtain the same information.This arrangement is less desirable, however, since the customer musttravel to the vendor's location to obtain the information.

Preferably, the program is arranged so that the customer selectsindividual components from the database and requests their combination.In response, the computer instantly displays the desired combination andindicates whether it is acceptable. For example, in the medical area,the computer database would contain information regarding whether aparticular combination of components meets FDA approval.

The means for ascertaining the combination components preferably allowsthe customer to choose products made by a wide variety of manufacturers.In this way, the customer may, if desired, choose components fromdifferent manufacturers to include in the combination. In thisarrangement, the database simply includes the necessary informationregarding the individual components, regardless of their source, andcombinations thereof.

According to a preferred embodiment, once the customer has put togethera given combination of products on the computer screen and the computerprogram has determined that the combination is acceptable, the customeris then permitted to place an order. Preferably, this order is placeddirectly through the computer which is being used to determine theproposed combinations of components.

When the customer places an order through the main computer, the maincomputer transmits the customer's order to a control office 42.Depending on the location of the main computer and the control office,this transmission may be through a direct connection, or when thecomputer and control office are far apart, through an electronicconnection such as the Internet or via fax, etc.

As stated above, desirably a computer program forms an integral part ofthe method, facilitating access to the component and componentcombination data, as well as permitting ordering.

As one aspect of the invention, a printer or similar device ispreferably provided at the kit factory 50 for printing out the order andinstructions which are to be provided with the components are to beassembled at the assembly location 52. The instructions may be arrangedto include pre-printed address labels for the assembly location 52 andcustomer 40 which are used to label the packages to each of theselocations.

Most importantly, the method of the present invention permits thecustomer to order any number of products.

Thus, the customer is not required to order a bulk order. As detailedbelow, the present invention is so efficient that bulk orders are notrequired to recoup assembly and administrative costs.

The control office 42 is preferably a small, stream-lined facility.There need not be many employees or extensive building space because thefundamental role of the control office is merely to receive electronicorders from the customer, send electronic instructions and receivestatus reports from other locations involved in the steps of the presentinvention.

In fact, much of the order processing may be carried out by a computersystem in the control office without the need for a great deal ofemployee involvement.

At or after the same time the order placed by the customer istransmitted to the control office 42, a corresponding order istransmitted to each supplier of the components comprising the desiredassembled product. The orders which are transmitted to the suppliers ormanufacturers of the components may be transmitted with the request tothe control office 42, such as in the same or substantially the samestep performed by the computer program or other protocol.

Preferably, when the control office 42 receives the customer's order,the control office immediately transmits the order. In the arrangementillustrated, a corresponding request or order is transmitted to threemanufacturers 44, 46, 48.

The order is also transmitted to a kit factory 50 associated with thevendors 44, 46, 48. This transmission is also preferably via a computernetwork.

The manufacturers' 44, 46, 48 involvement may be limited to justreceiving orders and sending individual components, a task to which theyare already well adapted. In that regard, the orders transmitted theretoare preferably for the manufacturer to deliver or transport the desiredcomponents to the kit factory 50.

In this arrangement, the kit factory 50 is a facility which desirablyhas very little storage capacity for component parts. The reduction intotal inventory contributes to a lower cost of production.

Instead, the kit factory 50 simply serves as a location where orders arereceived and to which component parts from the manufacturers are amassedand then sent to an assembly location. As a result, the kit factoryoperates as economically as possible.

In a preferred arrangement, the kit factory 50 has some inventory,permitting immediate amassing of the necessary parts for forwarding tothe assembly location 52. In this arrangement, the orders are placedwith the manufacturers 46,48,50 to provide immediate replacement of thedepleted minimal inventory.

The respective manufacturers 44,46,48 transport their requestedcomponents to the kit factory 50. The components may be transported bytruck, airplane or any means known to those of skill in the art.

The components arrive at the kit factory a short time, preferably thesame day, or within a few days after the customer's order is firstreceived. In that event, if insufficient inventory existed, the time toreceive additional components is minimal, and used inventory isimmediately replenished. To reduce the cost associated withtransportation, the kit factory 50 is desirably located close to themanufacturers 44,46,48, but also close to an assembly location 52,described below.

An employee at the kit factory 50 then rapidly amasses the separatecomponents from the manufacturers together with assembly instructionsregarding how the components are to be combined. In a preferredembodiment, the description consists of a simplified schematic picturegenerated by the computer system of the combined components. The pictureis desirably included in the package containing the separate componentsand the package is then sent to the assembly location 52. The picture orother instructions may contain a bar code which is read at each step ofthe process so that the computer will record exactly where anyparticular order is. A customer may be given access to the bar codesystem to “track” the progress of the customer's orders.

Of course, in alternative embodiments, any of the locations where themethod steps are performed may be combined, or the locations may be veryclose to each other, such as different rooms in the same building.

In order to further limit the total cost of producing the desiredcombination of component products, the assembly location 52 ispreferably situated in a place where labor costs are substantiallylower, such as a foreign country (such as Mexico), thereby significantlydiminishing the cost of assembly. The components are quickly combinedinto the desired combinations by the personnel at the assembly location52 with reference to the schematic picture or other assemblyinstructions which are conveniently provided along with the bulkcomponents.

After assembly, the products may be sent to a post-production location54. In the case of medical devices, this location comprises asterilization and packaging facility. In that arrangement, the assembledcombinations are therefore sent from the assembly location 52 to asterilization plant 54. After sterilization and packaging, the productsare then preferably sent directly to the customer 40. Alternatively, theproducts may be sent to a hub which then distributes the products tocustomers, as will be understood by those of skill in the art.

In the preferred embodiment, the method of manufacture is utilized tocreate medical devices from individual components. An example of themethod is utilized to create a medical device will be described withreference to FIGS. 1 and 4.

A customer is interested in obtaining the assembled product illustratedin FIG. 1 and described above. The customer accesses the vendor's maincomputer containing the above-referenced database. The customer locateseach of the individual components of the product in the database. Inthis case, the components include a standard CLAVE connector 28, tubing20, Y-site 24, adapter 26 and PIGGY LOCK'D connector 30. (The remainingcomponents shown in FIG. 1 will not be described for simplicity.) Thecustomer instructs the main computer to create a “cyber” version ofthese components assembled into the desired product configuration 98.This product configuration is illustrated on the screen of the customer,as illustrated in FIG. 4 at 100. The screen preferably displays dataregarding the cost per unit of the product 102 and whether thecombination can be produced in light of governing regulations 104.

If the combination is approved, the customer orders a quantity of theproduct. This order is received at the control office 42. Eithersimultaneous with the customer's order, or at or near the time ofreceipt thereof at the control office 42, an order is sent to themanufacturer or supplier of each of the individual components,requesting their delivery to the kit factory 50.

Upon receipt of the individual components, an employee at the kitfactory 50 prepares a package containing the raw materials, i.e.components, necessary for assembly of the final product. In this case,if 100 of the product illustrated on the customer's computer screen havebeen ordered, at least 100 of each of items 20, 24, 26, 28 and 30 areplaced into the package. In addition, an instruction and data sheet isprovided with this package. This sheet preferably contains dataregarding the order, the customer and how the individual components areto be assembled to complete the combination.

The assembly instructions preferably include a pictorial representationof the assembled product which may be used as a guide in the assemblyprocess.

This package is delivered to the assembly location 52. At this location,the instructions are utilized to assemble the completed product from theindividual components. The assembled products are then placed into apackage and delivered to the sterilization facility 54. At thisfacility, each product is sterilized and/or packaged. The products arethen delivered to the customer 40 or a distribution hub.

Many advantages are realized using the above-described invention. First,the method of the present invention provides products to customers muchfaster than conventional methods. In fact, customers may receive theproducts ordered in a few days as opposed to weeks or months later. Inaddition, the cost to manufacture the products is dramatically reduced.Samples do not need to be produced, and inventory is kept to a minimumas described above.

The above is a description of the application of the method of thepresent invention to a single product. Those of skill in the art willappreciate how the method may be applied to create a wide range ofproducts from individual components.

Of course, the foregoing description is that of preferred embodiments ofthe invention, and various changes and modifications may be made withoutdeparting from the spirit and scope of the invention, as defined by theappended claims.

1. A method of manufacturing a product from at least two individualcomponents comprising the steps of: providing data regarding at least afirst and a second component to a customer; permitting said customer torequest a product comprising the combination of at least said first andsaid second components; transmitting said request to a first locationremote from said customer; receiving at least one of said first andsecond components at said first location; transporting said first andsecond components from said first location to a second location;assembling said first and second components into the desired product atsaid second location; and transporting said assembled product to saidcustomer.
 2. The method in accordance with claim 1, further comprisingthe step of simultaneously transmitting a request to a supplier of saidfirst and or second component at the same time as said request istransmitted to said first location, requesting transport of said firstand/or second component to said first location.
 3. The method inaccordance with claim 1, wherein said components are medical devicecomponents.
 4. The method in accordance with claim 1, further includingthe step of transporting said assembled product from said secondlocation to a third location and sterilizing said product at said thirdlocation.
 5. The method in accordance with claim 1, further includingthe step of packaging said assembled product.
 6. A product comprising atleast one first and one second component, said product produced by:providing a database containing information regarding combinations of atleast a first and a second component, accessing said database todetermine the availability of a particular combination of components,placing an order for said combination, transmitting said order to afirst remote location, transmitting an order for each component to asupplier of that component, transportation said component to said firstremote location, amassing said components at said first remote location,transporting said components to a second location, assembling saidcomponents into said combination, and transporting said combination to adestination.
 7. The product in accordance with claim 6, furtherincluding the step of sterilizing said combination of assembledcomponents.